jRCT2031230402招募中不适用
[M14-682] A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib with a Tocilizumab Reference Arm in Subjects from 1 Year to Less than 18 Years Old with Active Systemic Juvenile Idiopathic Arthritis
AbbVie G.K.0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 主要终点
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 1age old over 至 18age old not（—）
- 性别
- All
入选标准
- •Baseline with a total body weight of 10 kg or higher at screening and a diagnosis of systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) criteria for at least 6 weeks prior to Screening, with onset prior to 16 years old, and meet the following conditions:
- •- Must have active sJIA with at least 2 active joints at Screening and Baseline, fever more than 38 Celsius for any out of 14 consecutive days before the Screening Visit, and an erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hsCRP) > 1.5 x upper limit of normal (ULN) at Screening. OR At least 5 active joints at Screening and Baseline and an ESR or hsCRP > 1.5 x ULN at Screening.
- •- Must have inadequate response to previous treatment with nonsteroidal anti-inflammatory drugs and systemic glucocorticoids, as judged by the investigator.
- •- For Cohort 1, participants must not have had previous treatment with any IL-6 inhibitor. For Cohort 2, participants must have an intolerance or inadequate response to an IL-6 inhibitor as judged by the investigator.
- •Note: For Cohort 1, participants must be ages 2 to < 18 years old in countries where subcutaneous tocilizumab is not approved for sJIA.
排除标准
- •Must have any type of juvenile idiopathic arthritis (JIA), other than sJIA, as defined by the ILAR criteria, and must not have a history or presence of any other autoimmune inflammatory condition other than sJIA.
- •Must have uncontrolled severe systemic disease and/or impeding or active macrophage activation syndrome within 3 months prior to Baseline.
结局指标
主要结局
Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
Percentage of participants achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 30 Response
次要结局
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 50 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 70 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 90 Response
- Percentage of Participants Achieving Adapted systemic Juvenile Idiopathic Arthritis (sJIA) American College of Rheumatology (ACR) 100 Response
- Change from Baseline in Number of Joints with Active Arthritis
- Change from Baseline in Number of Joints with Limitation of Motion
- Change from Baseline in Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI)
- Change From Baseline in Patient's Global Assessment (PtGA)
- Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA)
- Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
- Percentage of Participants with Absence of fever (> 38 Celsius) Attributed to systemic Juvenile Idiopathic Arthritis (sJIA)
- Change from Baseline in Glucocorticoid Dose
- Percentage of Participants Achieving Inactive Disease (ID) Status by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
- Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27-CRP)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
- Percentage of Participants Achieving Clinical Remission by Juvenile Arthritis Disease Activity Score (JADAS27)-CRP
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